Explore how patent cases from 2023-2025 caused significant generic drug delays, keeping prices high despite FDA approval. Learn about the 30-month stay, patent thickets, and real-world impacts on patients.
Explore how the FDA ensures generic drug safety through rigorous manufacturing oversight, bioequivalence testing, and global inspections under the Hatch-Waxman Act and GDUFA frameworks.
The Hatch-Waxman Act of 1984 created the legal framework that made generic drugs possible in the U.S., cutting costs by up to 90% and boosting access to affordable medicine. Here's how it works-and why it still matters today.
